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Ginkgo biloba extract EGb 761® in dementia with neuropsychiatric features: a randomised, placebo-controlled trial to confirm the efficacy and safety of a daily dose of 240 mg

Authors

Herrschaft, Horst, Nacu, Anatol, Likhachev, Sergey, Sholomov, Ilya, Hoerr, Robert, Schlaefke, Sandra

Journal

Journal Of Psychiatric Research, Volume: 46, No.: 6, Pages.: 716-723

Year of Publication

2012

Abstract

A multi-centre, double-blind, randomised, placebo-controlled, 24-week trial with 410 outpatients was conducted to demonstrate efficacy and safety of a 240 mg once-daily formulation of Ginkgo biloba extract EGb 761(®) in patients with mild to moderate dementia (Alzheimer’s disease or vascular dementia) associated with neuropsychiatric symptoms. Patients scored 9 to 23 on the SKT cognitive battery, at least 6 on the Neuropsychiatric Inventory (NPI), with at least one of four key items rated at least 4. Primary outcomes were the changes from baseline to week 24 in the SKT and NPI total scores. The ADCS Clinical Global Impression of Change (ADCS-CGIC), Verbal Fluency Test, Activities of Daily Living International Scale (ADL-IS), DEMQOL-Proxy quality-of-life scale and 11-point box scales for tinnitus and dizziness were secondary outcome measures. Patients treated with EGb 761(®) (n = 200) improved by 2.2 ± 3.5 points (mean ± sd) on the SKT total score, whereas those receiving placebo (n = 202) changed only slightly by 0.3 ± 3.7 points. The NPI composite score improved by 4.6 ± 7.1 in the EGb 761(®)-treated group and by 2.1 ± 6.5 in the placebo group. Both drug-placebo comparisons were significant at p < 0.001. Patients treated with EGb 761(®) also showed a more favourable course in most of the secondary efficacy variables. In conclusion, treatment with EGb 761(®) at a once-daily dose of 240 mg was safe and resulted in a significant and clinically relevant improvement in cognition, psychopathology, functional measures and quality of life of patients and caregivers.; Copyright © 2012 Elsevier Ltd. All rights reserved.

Bibtex Citation

@article{Herrschaft_2012, doi = {10.1016/j.jpsychires.2012.03.003}, url = {http://dx.doi.org/10.1016/j.jpsychires.2012.03.003}, year = 2012, month = {jun}, publisher = {Elsevier {BV}}, volume = {46}, number = {6}, pages = {716--723}, author = {Horst Herrschaft and Anatol Nacu and Sergey Likhachev and Ilya Sholomov and Robert Hoerr and Sandra Schlaefke}, title = {Ginkgo biloba extract {EGb} 761{textregistered} in dementia with neuropsychiatric features: A randomised, placebo-controlled trial to confirm the efficacy and safety of a daily dose of 240~mg}, journal = {Journal of Psychiatric Research} }

Keywords

adverse, aged, analysis of variance, biloba, complications, dementia, double-blind method, drug therapy, events, female, ginkgo, humans, male, mental disorders, methods, middle aged, neuropsychological tests, outcome assessment (health care), phytotherapy, plant extracts, psychiatric status rating scales, retrospective studies, therapeutic use, time factors

Countries of Study

Germany

Types of Dementia

Alzheimer’s Disease, Vascular Dementia

Types of Study

Randomised Controlled Trial

Type of Outcomes

ADLs/IADLs, Cognition, Other, Quality of Life of Person With Dementia

Type of Interventions

Pharmaceutical Interventions

Pharmaceutical Interventions

Herbal remedies, vitamins, dietary supplements